Unilateral Neck Radiotherapy in Head and Neck Cancer

Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery

Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life.

There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life.

Participants will be randomized into one of the following groups to receive radiotherapy as follows:

Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.

Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck); Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria:

• Age ≥18
• Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx.
• Squamous cell carcinoma confirmed by histology.
• Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with >= 10 lymph nodes removed from the contralateral neck
• The contralateral neck is pathologically negative
• Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes.
• Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

• Previous radiation to the head and neck area
• Pregnancy
• Other contraindications to radiation treatment (e.g. severe connective tissue disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-experimental intervention; Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck).	Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck); CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease
Experimental: Experimental intervention; Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck).	Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck); CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional control	Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.	At 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival and disease-specific survival	Percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.	5 years after diagnosis or the start of treatment.
University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification	The University of Washington Quality of Life questionnaire Radiation Therapy Oncology Group (RTOG) modification, is a health related quality of life tool for use in head and neck cancer patients receiving RT. The UW-QOL RTOG modification consists of 15 items with response options ranging from 10 to 50, in multiples of 10. That is, the lowest symptom burden is rated as 10, whereas the highest symptom burden is rated as 50. The individual item scores are totaled and then averaged to obtain the final score. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower HRQOL.	At 6, 12, 18 and 24 months post radiotherapy
Xerostomia	Overall score	At 6, 12, 18 and 24 months post radiotherapy
Acute toxicity	Toxicity scoring will be carried out to include salivary gland, mucositis, skin, and fatigue grading according the CTCAE version 4.0 scoring criteria.	Weekly throughout RT treatment (approximately 6 weeks)

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Collaborators: Cross Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: IIT-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No